18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEURO PULSE II,III
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Relievant Medsystems RF Generator
FDA 510(k)
FDA Class 2
·Neurology
BD TRITEST CD3/CD4/CD45, MODEL 340383
FDA 510(k)
FDA Class 2
·Hematology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·February 1, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·January 26, 2011
3.5MM X 16MM PRIMARY OPEN POLY SREW
FDA Adverse Event
Injury
·ZIMMER SPINE, INC.·Product code NKB·July 8, 2014
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·February 24, 2016
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
TOSOH AIA-900
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·December 13, 2016
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
A1A-600II
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·October 28, 2016
TOSOH AIA-1800
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·November 11, 2016
AIA-360
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code KHO·March 3, 2016
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026